This invention relates to a catheter assembly. More particularly, this invention relates to a catheter with a sterile sheath and to a catheter with a balloon at a distal end for anchoring the distal end of the catheter in an organ of a patient. This invention also relates to a method for inserting a catheter into a patient and to a method for anchoring the catheter in the patient.
In the medically assisted drainage of bladders, a Foley catheter is inserted through the urethra so that a distal end of the catheter is disposed in the bladder. A balloon attached to the distal end of the catheter is inflated to anchor or hold the catheter in the bladder to permit continued drainage of fluid from the bladder through the catheter. The balloon is inflated via a syringe connected to the balloon via a tube connected to the catheter. In order to determine that the balloon is properly positioned inside the bladder prior to the inflation of the balloon, the proximal end of the catheter is monitored for the flow of urine. The urine generally runs out over the patient and onto protective sheets which have been placed over and under the patient in the crotch area.
Thus, the conventional procedure for inserting a Foley catheter through a patient's urethra and into the bladder is a messy and delicate procedure. Great care must be taken in ensuring that the catheter does not come into contact with any nonsterile objects prior to insertion of the catheter through the urethra. Maintaining the sterility of the catheter is difficult insofar as the catheter is a flexible member and flops about prior to deployment in the patient's urethra. Moreover, although sterile gloves are provided in Foley catheter kits, the physician must frequently handle a number of potentially nonsterile objects immediately prior to inserting the catheter into the patient's urethra.
The difficulty in manipulating the catheter is exacerbated by the ancillary components attached to the catheter, including the syringe with the balloon pressurization fluid, and a urine collection bag.
A Foley catheter always comes enclosed in a sterile sheath or bag. Although some physicians attempt to manipulate the catheter through the sheath, to avoid contamination of the catheter during the insertion procedure, the sheath's construction militates against using the sheath as an insertion tool. The sheath does not collapse about the catheter, as required in such a procedure. Accordingly, the sheath is generally removed from the catheter, or at least from the distal end thereof, prior to an insertion or deployment procedure.
Once an anchoring balloon has been properly inflated via the syringe, the tube connecting the syringe to the anchoring balloon is closed, to prevent deflation of the balloon. The syringe is then removed and discarded. When the catheter is to be removed from the patient, another syringe must be connected to the catheter to draw the pressurization fluid from the anchoring balloon to deflate the balloon.
Catheters with anchoring balloons are used for other purposes, as well as to drain the bladder. For example, catheters are inserted into the stomach of some patients through incisions in the skin tissues to facilitate feeding of such patients. Endotracheal tubes are also used in some circumstances.